Comparison of RIMA-SVG and Ao-SVG Techniques in Coronary Artery Bypass Grafting

Comparison of RIMA-SVG and Ao-SVG Techniques in Coronary Artery Bypass Grafting : A Prospective Randomized Double-Blind Study on Graft Patency and Clinical Outcomes

This randomized, double-blind, single-center clinical trial was divided into two groups, RIMA-SVG and Ao-SVG, according to the surgical method. The purpose was to evaluate the effect of the RIMA-SVG surgical method in improving saphenous vein graft (SVG) patency and reducing clinical complications. A total of 300 patients will be enrolled and randomly assigned to two surgical method groups: RIMA-SVG Group (150 patients): SVGs are connected to the right internal mammary artery (RIMA). Ao-SVG Group (150 patients): The aorta is clamped, and SVGs are connected to the ascending aorta (Ao).All patients will undergo CABG on a beating heart with sequential vein grafts to bypass at least two or more coronary vessels. The primary outcome is 1-year graft patency. The secondary outcomes include neurological complications, mortality, major adverse cardiovascular events (MACE), and surgical site infection event.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Coronary Artery Bypass Grafting; Graft Patency; Saphenous Vein
• Intervention / Treatment: Procedure: RIMA-SVG; Procedure: Ao-SVG

Detailed Description

This randomized, double-blind, single-center clinical trial was divided into two groups, RIMA-SVG and Ao-SVG, according to the surgical method. The purpose was to evaluate the effect of the RIMA-SVG surgical method in improving saphenous vein graft (SVG) patency and reducing clinical complications. A total of 300 patients undergoing CABG on a beating heart will be randomized into two surgical technique groups: RIMA-SV Group (150 patients): SVGs are anastomosed to the right internal mammary artery (RIMA). Ao-SVG Group (150 patients): The ascending aorta is clamped, and SVGs are anastomosed to the aorta. All patients will undergo CABG via median sternotomy, and the left internal mammary artery (LIMA) will be used to bypass the left anterior descending artery (LAD). SVGs will be sequentially grafted to the circumflex artery, diagonal branch, and right coronary artery. The primary outcome is 1-year graft patency, assessed by coronary CT angiography and classified using the FitzGibbon grading system. Secondary outcomes include all-cause mortality, major adverse cardiovascular events (MACE), neurological complications, and surgical site infection event. Patients will be followed at 12 months for clinical evaluations and imaging assessments. Inclusion criteria include patients aged 18 to 80 years undergoing planned CABG with at least two sequential saphenous vein grafts and who are able to provide written informed consent. Exclusion criteria include additional cardiac surgeries, severe subclavian artery stenosis, unsuitable SVGs (e.g. bilateral varicosities), history of intracranial hemorrhage, active bleeding, malignancy, or emergency surgery. Randomization will be computer-generated, and all aspects of the study will remain blinded to ensure unbiased assessments.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • The Second Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patients aged 18 to 80 years.
2. Scheduled for their first planned coronary artery bypass grafting (CABG) with at least two sequential saphenous vein grafts (SVGs).
3. Able and willing to provide written informed consent.

Exclusion Criteria:

1. Patients unable to provide written informed consent.
2. Patients requiring other cardiac surgeries (e.g. valve replacement, congenital heart defect surgery, or aortic dissection repair).
3. Patients with severe stenosis of the left or right subclavian artery.
4. Patients for whom aortic clamping is infeasible due to calcification of the ascending aorta.
5. Patients with bilateral SVG varicosities unsuitable for grafting.
6. Patients with active malignancy.
7. Patients with active bleeding or a history of bleeding tendency.
8. Patients with previous intracranial hemorrhage, ischemic stroke within 14 days preoperatively, or severe carotid artery stenosis.
9. Patients with severe hepatic dysfunction.
10. Patients requiring emergency surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RIMA-SVG Group; Saphenous vein grafts (SVGs) will be connected to the right internal mammary artery (RIMA).	Procedure: RIMA-SVG; Saphenous vein grafts (SVGs) are connected to the right internal mammary artery (RIMA); Other Names: RIMA
Active Comparator: Ao-SVG Group; SVGs will be connected directly to the ascending aorta.	Procedure: Ao-SVG; The ascending aorta is clamped, and SVGs are anastomosed to the aorta.; Other Names: Ao

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-Year Graft Patency	The patency of saphenous vein grafts (SVGs) will be assessed 1 year post-surgery using coronary CT angiography	1 year post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological Complications	Incidence of neurological complications, including stroke within 1 year after CABG.	1 year post-surgery
Perioperative complications	Incidence of Perioperative complications related to CABG, including myocardial infarction, arrhythmias and other major adverse events.	2 weeks post-surgery
All-Cause Mortality	Incidence of MACCE, including cardiovascular death, non-fatal myocardial infarction, Incidence of death from any cause within 1 year after CABG.	1 year post-surgery
Major Adverse Cardiovascular Events (MACE)	Incidence of MACCE, including cardiovascular death, non-fatal myocardial infarction, and target vessel revascularization, within 1 year after CABG.after CABG.	1 year post-surgery
Surgical site infection event	Incidence of surgical site infection event during hospitalization and within 1 year	1 year post-surgery

Collaborators and Investigators

• Sponsor: Second Hospital of Jilin University
• Investigators: Study Director: kexiang liu, Ph.D., Second Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): January 22, 2025

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Major Adverse Cardiovascular Events; left internal mammary artery; Coronary Artery Bypass Grafting; Neurological complications; Saphenous Vein Graft; Graft Patency; Right Internal Mammary Artery; Surgical site infection event
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: JDEYXXGWK460

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) underlying the primary and secondary outcomes of the study-including baseline characteristics, graft patency results, perioperative complications, and 12-month clinical outcomes-will be made available upon reasonable request. Data will be shared with qualified researchers following study completion and publication, subject to approval by the trial steering committee and in accordance with ethical and data protection guidelines.
• IPD Sharing Time Frame: Data will be shared via request from the corresponding author starting 6 months after study completion and publication.
• IPD Sharing Access Criteria: Access to the de-identified individual participant data will be granted to qualified researchers whose proposed use of the data has been reviewed and approved by the trial's principal investigator and data access committee. Applicants must submit a detailed research proposal outlining the scientific rationale, intended analyses, and data protection measures. A data use agreement must be signed prior to data release to ensure compliance with ethical and legal standards.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No